Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease (REAL-SMART)

Cordis US Corp.

Status: Not yet enrolling

Conditions: Superficial Femoral Artery Stenosis; Popliteal Artery Stenosis; Iliac Artery Stenosis

Treatments: Device: S.M.A.R.T.™ Nitinol Stent System (SMART 120/150); Device: S.M.A.R.T.™ CONTROL ™ Nitinol Stent System; Device: S.M.A.R.T.™ Flex Vascular Stent System

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT07338890

P24-6202

Details and patient eligibility

About

The purpose of this study is to evaluate long-term safety and performance per the intended use of the S.M.A.R.T.™ Nitinol Stent System (SMART 120/150), S.M.A.R.T.™ CONTROL™ Nitinol Stent System (SMART CONTROL) and S.M.A.R.T.™ Flex Vascular Stent System (SMART Flex) in the treatment of iliac and femoropopliteal artery disease.

Full description

The REAL-SMART study is a multi-center, non-randomized, observational analysis of retrospective data collected on all subjects treated with SMART 120/150, SMART CONTROL or SMART Flex. The purpose of this study is to evaluate long-term safety and performance per the intended use of the three (3) study devices. Each device constitutes a separate study arm and each arm is further stratified by indication, of which there are two per device. The study is conducted in approximately 20 sites located in approximately three (3) European countries with high volume use of one or more of the study devices. The enrollment and data collection take approximately 6-8 months.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: For data mining purposes, the following criteria will apply in determining which subjects to include in the study:

• Subjects treated with SMART 120/150, SMART CONTROL or SMART Flex according to the respective Instructions for Use for treatment in the iliac, superficial femoral and/or proximal popliteal arteries.
• If an EC-approved informed consent waiver is not obtained, then documented informed consent from the subject or legal representative granting permission to share the subject's clinical data It is recommended to include subjects with follow-up data available for a minimum of five (5) years from the date of treatment/procedure or until time of death, whichever came first.

It is recommended to include subjects with follow-up data available for a minimum of five (5) years from the date of treatment/procedure or until time of death, whichever came first. Subjects not included because follow-up information is unavailable will be documented, wherever possible, with respect to demographics and presenting disease state to determine whether they are similar to subjects with follow-up that are enrolled.

Exclusion Criteria: For data mining purposes, the following criteria will apply in determining which subjects to exclude in the study:

• Women who were pregnant or lactating at the time of the procedure.
• Pediatric subjects (<18 years of age) at the time of the procedure.

Trial design

240 participants in 6 patient groups

Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART 120/150.

Description:

The Cordis S.M.A.R.T.TM Nitinol Stent System (SMART 120/150) is indicated in enabling treatment in patients with atherosclerotic disease of the superficial femoral artery (SFA).

Treatment:

Device: S.M.A.R.T.™ Nitinol Stent System (SMART 120/150)

Subjects with stenotic lesions of the proximal popliteal artery (PPA) treated with SMART 120/150.

Description:

The Cordis S.M.A.R.T.TM Nitinol Stent System (SMART 120/150) is indicated in enabling treatment in patients with atherosclerotic disease of the proximal popliteal artery (PPA).

Treatment:

Device: S.M.A.R.T.™ Nitinol Stent System (SMART 120/150)

Subjects with stenotic lesions of the iliac artery treated with SMART CONTROL.

Description:

The Cordis S.M.A.R.T.TM CONTROLTM Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of the iliac artery.

Treatment:

Device: S.M.A.R.T.™ CONTROL ™ Nitinol Stent System

Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART CONTROL.

Description:

The Cordis S.M.A.R.T.TM CONTROLTM Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of the superficial femoral artery (SFA).

Treatment:

Device: S.M.A.R.T.™ CONTROL ™ Nitinol Stent System

Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART Flex.

Description:

The Cordis S.M.A.R.T.TM Flex Stent is indicated in enabling treatment of patients with symptomatic vascular stenotic and/or occlusive diseases in the superficial femoral artery (SFA).

Treatment:

Device: S.M.A.R.T.™ Flex Vascular Stent System

Subjects with stenotic lesions of the proximal popliteal artery (PPA) treated with SMART Flex.

Description:

The Cordis S.M.A.R.T.TM Flex Stent is indicated in enabling treatment of patients with symptomatic vascular stenotic and/or occlusive diseases in the proximal popliteal artery (PPA).

Treatment:

Device: S.M.A.R.T.™ Flex Vascular Stent System